Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
  • A61B5/021—Measuring pressure in heart or blood vessels
  • A61B5/022—Measuring pressure in heart or blood vessels by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
  • A61B5/02233—Occluders specially adapted therefor
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
  • A61B17/132—Tourniquets
  • A61B17/135—Tourniquets inflatable

Definitions

• the present invention relates to methods and apparatus for regulating tourniquet pressure.
• an automatic tourniquet system including variable pressure cuff apparatus for applying a variable pressure to a limb or artery of a patient in order to occlude blood flow thereat and control apparatus for determining the operative pressure of the variable pressure cuff appa- ratus and including apparatus for estimating the mini- mum effective cuff pressure required for complete occlusion.
• automatic tourniquet system including variable pressure cuff apparatus for applying a variable pressure to a limb or artery of a patient in order to occlude blood flow thereat and control apparatus for determining the operative pressure of the variable pressure cuff appa- ratus and including apparatus for monitoring the blood pressure of a patient and apparatus for determining the operative pressure as the product of blood pressure and a factor.
• the blood pressure used in the apparatus for determining is a weighted combina- tion of the systolic and diastolic blood pressures.
• the factor is selected according to at least one of the following: the limb or artery on which the cuff apparatus is mounted, the size of the cuff apparatus, .and whether the patient is an adult or a child.
• the control apparatus includes apparatus for causing the cuff apparatus to apply an initial pressure which is at least twice the blood pressure for a predetermined limited time.
• the initial pres- sure is a constant for a limb/artery.
• the predetermined limited time is less than 10 minutes.
• the weighted combination is the mean blood pressure.
• the apparatus for monitoring includes apparatus for measuring the systol- ic and diastolic blood measure.
• a tourniqueting method including the steps of: a. providing two or more adjacent occlusive cuffs, b. inflating the first cuff, c. after a predetermined or user-selected time interval, inflate the second cuff, d.
• an automatic tourniquet technique including the steps of applying a variable pressure to a limb or artery of a patient in order to occlude blood flow thereat and determining the operative pressure of the variable pressure cuff apparatus and including the steps of monitoring the blood pressure of a patient and setting the operative pressure as the product of blood pressure and a factor.
• the blood pressure used in the determining step is a weighted combination of the systolic and diastolic blood pressures.
• the factor is selected according to the limb or artery on which the cuff apparatus is mounted.
• the determining step includes causing the cuff apparatus to apply an initial pressure which is at least twice the blood pressure for a predetermined limited time. Additionally in accordance with a preferred embodiment of the present invention, the initial pres- sure is a constant for a limb/artery. Still further in accordance with a preferred embodiment of the present invention, the predetermined limited time is less than 10 minutes. Additionally in accordance with a preferred embodiment of the present invention, the weighted combination is the mean blood pressure. Further in accordance with a preferred embod- iment of the present invention, the monitoring step includes measuring the systolic and diastolic blood measure.
• auto- matic tourniqueting apparatus for controlling infla- tion and deflation of two or more adjacent occlusive cuffs, including an occlusive cuff inflation/deflation signal generator operative to provide control signals suitable for implementing at least some of the steps of the following schedule: a. inflating the first cuff, b. after a predetermined or user-selected time interval, inflate the second cuff, c. once the second cuff is inflated, de- flate the first cuff, thereby relieving pressure on the first cuff body site, d. after a predetermined or user-selected time interval, inflate the first cuff, e.
• apparatus for automatically performing an IV regional anesthesia for use in conjunction with a double tour- niquet cuff system including a proximal cuff and a distal cuff and a cuff inflation/deflation device
• the apparatus including a double tourniquet cuff control unit operative to control the cuff inflation/deflation device according to a proximal and distal cuff infla- tion and deflation schedule.
• the schedule includes: a. in response to a user's signal, proximal cuff inflation until a particular relatively high cuff pressure is reached, b.
• the distal cuff defla- tion schedule includes a schedule of alternating infla- tions and deflations of the distal cuff.
• the inflation and deflation schedule is determined according to at least one user input.
• the at least one user input includes at least one of the following: determination of a relatively high pressure for at least one of the distal and proximal cuffs, indication of a limb/artery, cuff size.
• an automatic tourniquet system including a tourniquet control signal generator operative to provide a first control signal operative to induce a relatively high tourniquet pressure suitable for establishing a blood- less field and subsequently to provide a second control signal operative to induce a relatively low tourniquet pressure suitable for maintaining the bloodless field.
• automatic tourniqueting apparatus for controlling inflation and deflation of two or more adjacent occlu- sive cuffs including an occlusive cuff inflation/deflation signal generator operative to provide control signals suitable for implementing at least some of the steps of the following schedule: a. inflating the first cuff, b.
• Fig. 1 is a simplified block diagram illus- tration of a tourniquet pressure regulating system constructed and operative in accordance with a pre- ferred embodiment of the present invention which commu- nicates with an external supply of compressed air
• Figs. 2A and 2B taken together, are a sim- plified flowchart of the operation of operation and control unit of Fig. 1
• Fig. 3 is a simplified flowchart of a pre- ferred method for performing an initialization step in the flowchart of Figs. 2A and 2B;
• Figs. 1 is a simplified block diagram illus- tration of a tourniquet pressure regulating system constructed and operative in accordance with a pre- ferred embodiment of the present invention which commu- nicates with an external supply of compressed air
• Figs. 2A and 2B taken together, are a sim- plified flowchart of the operation of operation and control unit of Fig. 1
• FIG. 4A and 4B taken together, are a sim- plified flowchart of a branch of the flowchart of Figs. 2A and 2B, for an instance in which a Bier's block procedure is to be performed;
• FIG. 5 is a pictorial illustration of a display and control panel forming part of the user input and display panel unit of Fig. 1;
• Fig. 6 is a simplified flowchart of a method for using a plurality of occlusive cuffs to maintain a bloodless field for an extended period of time without pressuring a single site for an extended period of time.
• Appendix A which aids in the understanding and appreciation of one preferred embodiment of the invention shown and de- scribed herein.
• Fig. 1 is a simplified block diagram illustration of a tourniquet pressure regulating system, referenced generally 10, which is constructed and operative in accordance with a preferred embodiment of the present invention.
• the tourniquet pressure regulating system 10 includes a blood pressure transducer 20, which typical- ly comprises a commercially available occlusive cuff and is operative to provide an indication of blood pressure.
• the blood pressure indication provided by blood pressure transducer cuff 20 is provided to a blood pressure monitor 30 which is operative to pro- vide a display and/or an output indication of at least one blood pressure characteristic which may be the output of blood pressure transducer 20 or some parame- ter or characteristic computed or generated therefrom.
• the blood pressure monitor 30 may provide an output indication of mean blood pressure, namely, the following weighted combination: 1/3 x systolic blood pressure + 2/3 x diastolic blood pressure
• mean blood pressure namely, the following weighted combination: 1/3 x systolic blood pressure + 2/3 x diastolic blood pressure
• DINAMAP Vital Signs Monitor Model 8100, commercially available from Critikon, Inc., Tampa, FA, USA. Principles of operation of blood pressure monitors are described in Monitoring in anesthesia and critical care medicine. 2nd Ed., Casey D. Blitt, M. D., Churchill Livingstone, 1990.
• Blood pressure signals are provided by the blood pressure monitor 30 to an operation and control unit 40 which is operative to provide the following information: a.
• the operation and control unit 40 provides, to a pressurized gas supply system 50, an estimate of a minimum effective tourniquet pressure required to maintain an established bloodless field. b. The operation and control unit 40 preferably inspects the blood pressure profile and particularly the rapidity of fluctuation thereof and provides to blood pressure monitor 30 an indication of a suitable time interval for blood pressure measurement, indicat- ing how frequently it is necessary to measure blood pressure. c.
• the opera- tion and control unit 40 controls operation of pressur- ized gas supply system 50 so as to provide appropriate pressures for each of the two tourniquet cuffs employed in a Bier's block procedure, according to an appropri- ate schedule which preferably responds to a user's input.
• pressur- ized gas supply system 50 so as to provide appropriate pressures for each of the two tourniquet cuffs employed in a Bier's block procedure, according to an appropri- ate schedule which preferably responds to a user's input.
• Pressurized gas supply system 50 typically comprises an air pump 52, an associated valve system 54 and a pressure transducer 56. Pressurized gas supply system 50 provides inflation and deflation of a tourniquet cuff 60.
• Tour- niquet cuff 60 may comprise any commercially available tourniquet cuff such as one of the series of reusable tourniquet cuffs, commercially available from Smith & Nephew Richards Inc., Memphis, TN, USA or such as one of the series of disposable tourniquet cuffs, commer- cially available from Smith & Nephew Richards.
• tourniquet cuff 60 may comprise a dual cuff suitable for performing Bier's block procedures, i.e. IV regional anesthesia procedures.
• Dual cuffs are also commercially available from Smith & Nephew Richards.
• the user of the system 10 may select any of a plurality of cuffs, varying in size, such as cuffs within a single series, to implement tourniquet cuff 60 and the operation and control unit 40 takes into account the size of the cuff as indicated by the user when estimating the minimum effective tourniquet pressure, all of which are provided integrally with the system.
• blood pressure cuff 20 and tourniquet cuff 60 may either be on the same limb or on opposite limbs.
• cuffs 20 and 60 may be replaced by a single double-module cuff which performs the blood pressure measurement function of cuff 20 and the tourniquet function of cuff 60.
• a preferred method for implementing operation and control unit 40 is described below in further detail with reference to Figs. 2A and 2B.
• Operation and control unit 40 is associated with a user input and display panel 80.
• a description of a preferred configuration for panel 80 is provided below with reference to Fig. 5.
• Figs. 2A and 2B which, taken together, are a simplified flowchart showing operation of the operation and control unit 40 of Fig.
• Step 200 This initialization step is preferably performed prior to any operational use of the unit 40.
• a good tourniquet cuff pres- sure value for maintaining an already established bloodless field may be computed by multiplying ongoing readings of blood pressure, such as mean blood pressure readings, by a factor which depends on the type of limb, the size of tourniquet cuff and, typically, the age group (adult/pediatric)
• the above experimental results are reported in a not-yet published article by 0. Levy, Y. David, M. Heim, I. Eldar, A. Chetrit and J.
• step 200 a table is constructed which stores values for the above constant, termed herein A, for a variety of limb types, tourniquet cuff sizes, and, preferably age groups.
• a preferred method for performing step 200 is described below with reference to Fig. 3.
• unit 40 prompts the user through a set-up session in which the user is prompted to define each of a plurality of general parameters which are stored in a parameter table 82 (Fig. 1), such as the following parameter table: PARAMETER TABLE
• PROCEDURE-SPECIFIC LIMB (ARM/LEG/MAJOR ARTERY)
• CUFF SINGLE/DUAL
• CUFF SIZE PATIENT AGE GROUP ADULT/PEDIATRIC
• the user is prompted to select a pressure with which a bloodless field is to be estab- lished in the arm, in the leg and in a major artery.
• the user is also preferably prompted to select "opera- tor requested pressure increments" (ORPI's), both for single cuff procedures and for each of the proximal and the distal cuffs employed in Bier's block procedures.
• ORPI's may be selected differently for the arm, for the leg and for a major artery.
• the system adds the appropriate ORPI to its own estimation of the minimum tourniquet pressure required to maintain a bloodless field.
• the user also preferably selects a maximum time after which it is believed desirable to perform reperfusion.
• the system preferably provides an audio alarm to indicate that this time has elapsed.
• the most recently selected previous value is stored in the parameter table 82.
• system default values are stored in the parameter table 82, such as the values indicated in the above parameter table.
• Pressure values are given in units of mm Hg. Time values are given in minutes.
• Step 220 Read the general parameters from the parameter table 82.
• Step 230 If a start key has been punched on the display and user input panel 80 of Fig.
• the system prompts the user to provide at least one proce- dure-specific value which characterizes an individual operation on an individual patient, such as the follow- ing: i. type of limb — arm or leg or major artery ii. type of cuff — single or dual.
• a dual cuff procedure is also termed herein a Bier's block procedure. iii. cuff dimensions or cuff size. iv. patient age group. Typically age groups include a single adult age group and one or more pedi- atric age groups.
• Step 240 Update the parameter table 82 according to the inputs received in step 230.
• Step 250 Provide a control indication to blood pressure monitor 30 including an indication of a time interval between blood pressure measurements, such as the minimum time interval supported by the blood pressure monitor 30, or approximately 2 - 2.5 minutes.
• Step 260 Receive mean blood pressure meas- urements from blood pressure monitor 30 and conduct an ongoing analysis thereof, including continuous computa- tions of the average mean blood pressure and of the variance of the blood pressure, over a moving window of, typically, 5 measurements.
• Step 262 If the parameter table 82 indicates that a single cuff procedure is being followed, go to step 270. Otherwise, go to Fig. 4A.
• Step 270 Provide an initial inflating control indication to pressurized gas supply system 50 including the bloodless field establishing pressure stored in the table 82, also termed herein the EP, and a time interval during which the establishing pressure is to be applied. Typically, the time interval is predetermined. A suitable value is, for example, 3 minutes. A particular feature of the present invention is that, once a bloodless field has been established, the tourniquet cuff pressure is reduced so that a lower value is used to maintain the bloodless field than is used to establish the bloodless field.
• Step 280 An appropriate A value is read from the A table constructed in step 200, according to the following procedure-specific parameters read from the parameter table 82: limb, cuff size, patient age group.
• Step 290 On an ongoing basis, such as at the same frequency at which blood pressure is being measured, an inflating or deflating control signal is provided to pressurized gas supply system 50 of Fig. 1.
• the inflation/deflation control signal indicates the extent of inflation/deflation required to move from the current tourniquet pressure in tourniquet 60 to a newly computed tourniquet pressure.
• the system-computed tourniquet pressure comprises an estimated minimum pressure required to maintain a bloodless field (MP) , to which is preferably added the user-selected ORPI value.
• the MP value is estimated as follows: a.
• the current mean blood pressure is multiplied by the A value accessed in step 280. b.
• the product computed in substep a is incremented by a blood pressure fluctuation (BPF) factor.
• the BPF factor may be established during ini- tialization for each of a plurality of blood pressure variances and for each of a plurality of blood pressure measurement frequencies, and may be stored in a table.
• the BPF factor table may then be accessed as a function of the current blood pressure measurement frequency (step 300) and of the current blood pressure variance as computed in step 260.
• the BPF factor is large to the extent that the blood pressure variance is large and the blood pressure measurement frequency is small.
• the BPF factor may be a constant which is determined in step 422 of Fig. 4 for each age group, limb type and cuff size.
• Each entry in the BPF factor table is select- ed such that fluctuations of more than a predetermined number of standard deviations will not occur, at a predetermined statistical confidence level.
• the BPF factor value may be selected so as to prevent fluctuations of more than two standard devia- tions at a level of confidence of 95%. Fluctuations in blood pressure may be fore- casted by use of exponential smoothing, which is a known statistical technique.
• Step 300 On an ongoing basis, such as once per blood pressure measurement, starting from after the first 3 or 5 blood pressure measure- ments, a signal indicative of an appropriate blood pressure measurement frequency is transmitted to blood pressure monitor 30 of Fig. 1.
• the signal indicates that the blood pressure measurement frequency should increase, and conversely, if the variation is small, the blood pres- sure measurement frequency may be decreased.
• the recommended blood pressure measurement frequency is computed as follows: a. Fluctuations in blood pressure are forecasted by use of exponential smoothing. b. A frequency is selected such that fluctuations of more than a predetermined number of standard deviations will not occur, at a predetermined statistical confidence level, before the next blood pressure measurement. For example, the frequency may be selected so as to prevent fluctuations of more than two standard deviations at a level of confidence of 95%.
• Step 310 Preferably, status information is displayed on display panel 80 of Fig.
• Step 320 If the time elapsed since the second time the start button is pressed exceeds the reperfusion time interval defined in the parameter table 82, an alarm is provided, such as an audio alarm.
• Step 330 Once the user indicates, as by using stop key 530 of panel 80 of Fig. 5, that the surgical procedure has been completed, a suitable deflation control signal is provided to pressurized gas supply system 50.
• the deflation control signal may comprise a signal to deflate the cuff.
• Fig. 3 is a preferred method for implementing initialization step 200 of Fig. 2A in which a look-up table for the "A" parameter is constructed.
• Step 400 Select a sample of approximately 400 patients which is representative of the patients within the age group as to sex, age and medical condi- tion.
• Step 410 Take approximately 3 measurements, separated by 15 minute time intervals, of blood pres- sure and of Doppler opening pressure (DOP) .
• DOP Doppler opening pressure
• the A value for the individual entry is the slope of the linear regression.
• Step 422 It is believed that a suitable method for computing the BPF factor employed in step 290 is by computing the standard error of the Y axis intercept for each age group, limb type and cuff size.
• Step 430 Store the A value of step 420 in the location in the A table which corresponds to the individual limb, cuff size and, preferably, age group. Further details on how to carry out the method of Fig. 3 are described in Appendix A.
• a suitable value of A, for the arm, for a cuff of width 5.5 cm and for an adult popu- lation is 2.04.
• Figs. 4A - 4B which, taken together, comprise a preferred method for imple- menting operation and control unit 40 for instances in which the user has indicated, in step 262 of Fig. 3A, that a Bier's block dual cuff procedure is being em- ployed. If the user has so indicated, the method of Fig. 4A may be employed. If the flow of Fig. 4A is interrupted by a patient discomfort indicator, such as via the "start" button 520 of Fig. 5, the method of Fig. 4B may be employed.
• FIG. 5 is a pictorial illustration of user input and display panel of Fig. 1.
• the display and control panel of Fig. 5 preferably includes the follow- ing elements: a. An on/off button 510. When the button 510 is in its on position, the system is in stand-by mode and awaits further inputs. b. A start button 520; c. A stop button 530; d. A "manual" button 540 enabling the user to select a manual mode of operation; e. A "set-up” button 542 enabling the user to select a set-up mode of operation; f. a display panel 546; g. An input value selecting mechanism such as a scroll 550 which allows a user to indicate whether he wishes to increase or decrease an existing numerical value.
• a scroll 550 which allows a user to indicate whether he wishes to increase or decrease an existing numerical value.
• the above schedule has the advantage of allowing a bloodless field to be maintained for a long time period, however, pressure on each individual tourniqueted location is provided only a portion of the time period, such as half of the time period.
• the above schedule is particularly useful in applications wherein anesthetic is provided proximally of the tourniqueted areas, such as in procedures carried out under general anesthesia. It is appreciated that various features of the invention which are, for clarity, described in the contexts of separate embodiments may also be provided in combination in a single embodiment. Conversely, various features of the invention which are, for brevi- ty, described in the context of a single embodiment may also be provided separately. It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereina- bove. Rather, the scope of the present invention is defined only by the claims that follow:

Landscapes

• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Vascular Medicine (AREA)
• Surgery (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Cardiology (AREA)
• Veterinary Medicine (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Medical Informatics (AREA)
• Molecular Biology (AREA)
• Animal Behavior & Ethology (AREA)
• Biophysics (AREA)
• Dentistry (AREA)
• Pathology (AREA)
• Reproductive Health (AREA)
• Ophthalmology & Optometry (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Physiology (AREA)
• Physics & Mathematics (AREA)
• Hematology (AREA)
• Surgical Instruments (AREA)
• Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)
• Constituent Portions Of Griding Lathes, Driving, Sensing And Control (AREA)
• Massaging Devices (AREA)
• Eye Examination Apparatus (AREA)
• Paper (AREA)

Applications Claiming Priority (3)

Publications (2)

Family

ID=11064712

Family Applications (1)

Country Status (9)

Cited By (1)

Families Citing this family (46)

Family Cites Families (25)

• 1993
  • 1993-04-04 IL IL10530693A patent/IL105306A/xx not_active IP Right Cessation
• 1994
  • 1994-03-31 AT AT94913522T patent/ATE171607T1/de not_active IP Right Cessation
  • 1994-03-31 DE DE69413680T patent/DE69413680T2/de not_active Expired - Lifetime
  • 1994-03-31 AU AU65649/94A patent/AU6564994A/en not_active Abandoned
  • 1994-03-31 DK DK94913522T patent/DK0692949T3/da active
  • 1994-03-31 WO PCT/EP1994/001044 patent/WO1994022364A1/en active IP Right Grant
  • 1994-03-31 US US08/530,317 patent/US5842996A/en not_active Expired - Lifetime
  • 1994-03-31 ES ES94913522T patent/ES2126108T3/es not_active Expired - Lifetime
  • 1994-03-31 EP EP94913522A patent/EP0692949B1/de not_active Expired - Lifetime
• 1998
  • 1998-09-24 US US09/159,551 patent/US6299629B1/en not_active Expired - Lifetime

Non-Patent Citations (1)

Also Published As

Similar Documents

Legal Events